Summary
Established and productive individual contributor, who works under moderate supervision. Performs duties related to the development of business requirements, flowcharts and systems to the documentation of user requirements. Implements systems for controlling, monitoring, measuring, executing, designing, and evaluating business processes.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Business Process QualityJob Category:
ProfessionalAll Job Posting Locations:
CO015 One JNJ Bogota BuildingJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for COMMERCIAL QUALITY SPECIALIST FOR DISTRIBUTION CENTER to be in One J&J Bogota, Zona Industrial de Montevideo and Zona Industrial de Siberia (1 day per week in each site)
Purpose:
Responsible for supporting end-to-end quality operations within the Northern Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson MedTech. Establishing/maintaining quality assurance programs verifying that products meet their specifications and ensure that all elements of the quality management system follow the requirements of applicable local regulations. Give support to the management of the Qualified Person (Technical Director) role.
You will be responsible for:
According to the Business requirements and leading strategy the main activities of this role can be some of the above
Coordinate and supervise the distribution centers, monitoring and ensuring the implementation of both corporate and local regulatory guidelines and standards.
Supports the implementation of company standards such as: Temperature Control, Loaner Kit and Repack and Relabel Compliance, among others, as applicable.
Support regional business and QMS activities and processes when applicable.
Provide support for the implementation and maturity of the quality management system, supporting Non-Conformances, CAPA's and Change Controls processes and ensuring the correct implementation of the other pillars of the quality management system in the Northern Cluster.
Guides the different stakeholders of Commercial Quality in the opening, execution and follow-up of CAPA's, NC management, change control process and escalations in accordance with the company's standards and processes.
Support compliance with Good Practices and Regulations for Medical Devices aligned with EHS requirements among other company policies within the Distribution Centers.
Report and display metrics / Dashboards for the quality indicators of Commercial Quality and 3PLs, carrying out follow-up, analysis and/or trend monitoring activities.
Coordinate the Gemba Walk tours in the facilities of the 3PLs and ensure the follow-up of the closure of findings in a correct way and in a timely manner.
Supervise the product disposition process in the distribution centers in charge.
Support the supervision and execution of Field Action and Stop Shipments processes.
Leadership, development, and supervision of the team in charge when applicable.
Participate and lead continuous improvement projects to achieve efficiencies in the company, supporting the concepts of Quality and ensuring compliance with company standards when applicable.
Support reporting processes to regulatory agencies when applicable (Pharmacovigilance and Techno-vigilance).
Management of corporate and local tools that support the quality system (Designated Electronic System (DES)).
Participate in the planning, execution and reception of Quality audits of different types such as Internal, External, Regulatory, etc.
Ensures compliance with the supplier management standard and the timely renewal of quality agreements with the suppliers in charge.
Surveillance of regulatory compliance for logistics operators, including monitoring the renewal of the operating license with local health entities.
Support and execute any other activity that the immediate manager deems appropriate.
Provide technical advice to the legal representative and areas of the Business, Service Solutions, Planning, Regulatory, Deliver, among others, regarding the characteristics of Medical Devices, as well as meeting all the requirements of local regulations regarding the quality of those devices, participating and leading continuous improvement projects to achieve efficiencies in the company by providing Quality concepts and ensuring compliance with company standards when applicable.
Support the selection process of suppliers and distributors of the company specific to 3PLs.
Approve procedures related to storage, conditioning, dispatch and distribution operations when applicable.
Guarantee the maintenance of the conditioning and storage areas and in general of all the facilities where operations with Medical Devices are carried out when applicable.
Ensure, through monitoring and control, the traceability of Medical Devices when applicable.
Be responsible for the process of complaints and recalls of Medical Devices. As well as being responsible for monitoring adverse events that may arise and reporting them to the Health Authority. Be responsible for giving decisions on the use of the products: Imported, conditioned, returned, rejected, recalled or falsified when applicable.
Be responsible for the inspection and/or packaging activities of Medical Devices when applicable.
Be responsible for maintaining the quality of Medical Devices and represent J&J before the Health Authority when necessary.
Qualifications / Requirements:
- Bachelor Degree in Pharmaceutical Chemist, Biomedical Engineer, Surgical Instrumentation, Chemical Engineer, Industrial Engineer or related careers.
- 5 years of related experience in the pharmaceutical or medical device sector.
- Experience in the implementation of elements of the Quality Management System.
- Experience in leading Quality events such as Non-Conformities, CAPAs, Change Controls, etc.
- Strong in technological developments for improve and make processes efficient.
- Experience leading projects and teams with multifunctional stakeholders.
Advanced English
Portuguese is a plus.
